Laboratory equipment and reagents

• Directive 2014/35/EU — Low Voltage
• Directive 2014/30/EU — EMC
• Regulation (EU) 2023/1230 — Machinery for moving equipment
• Regulation (EC) No 1272/2008 — CLP for reagents
• Regulation (EU) 2017/746 — IVDR where used for diagnosis

Who has to appoint one

Manufacturers outside the Union placing laboratory instruments and reagents on the EU market. Research use only products avoid the IVDR, but only if they genuinely are not intended for diagnostic purposes, and the marketing must support that.

Thresholds and exemptions

None for the electrical and machinery rules. The IVDR applies where the product is intended for in-vitro examination of specimens for diagnostic purposes.

What must appear on the label

CE marking, manufacturer and EU representative details, model and serial number, rated electrical data, and for reagents the CLP information with the UFI. IVD products carry the IVD symbol, the UDI and the EC REP details.

Marketplace fields

Distributors require the declaration of conformity, and reagents shipped across borders face dangerous goods and, for biological materials, additional transport requirements.

Documentation you must hold

EU declaration of conformity, technical file with electrical, EMC and where applicable machinery risk assessment, CLP classification and safety data sheets for reagents, and IVDR technical documentation where the product is diagnostic.

Standards and testing

EN 61010-1 for laboratory equipment safety, with the relevant part 2 for centrifuges, autoclaves and heating equipment, EMC testing, and for IVDs analytical and clinical performance evaluation.

Language requirements

Instructions and safety data sheets in the language of each member state where the product is placed on the market.

When it applies

Before placing on the market. IVDR transitional deadlines run to 2027 and 2028 by class.

How long records are kept

Ten years, or the IVDR periods where applicable.

What happens if you do not comply

Withdrawal and prohibition of sale. Labelling a diagnostic product as research use only to avoid the IVDR is treated as circumvention rather than as a classification choice.

Who enforces it

Market surveillance authorities, medical device competent authorities for IVDs, chemicals authorities for reagents and customs.

Where the boundary lies

EN 61010 rather than EN 62368 governs laboratory equipment safety, which manufacturers of consumer electronics often miss. And the research use only label protects nothing if the product is marketed to clinical laboratories for patient testing.

Questions we are asked

Is research use only a valid exemption?

Only where the product genuinely is not intended for diagnostic use. Authorities look at the marketing, the customers and the instructions, not the sticker.

Which safety standard applies to a centrifuge?

EN 61010-1 with EN 61010-2-020, plus the machinery risk assessment for the rotating assembly.